This invention relates generally to medical devices and methods of detection and treatment of cancer, and more particularly to minimally invasive medical systems including a radiation detecting probe for locating radioactively tagged tissue, e.g., a xe2x80x9csentinelxe2x80x9d lymph node, within the body of the patient and for retrieving or removing that tissue.
The use of radioactive materials to tag tissue within a patient for effecting its localization and demarcation by radiation detecting devices has been disclosed in the medical literature for at least forty years. Significant developments in the localization and demarcation of tissue bearing radioactive isotope tags for diagnostic and/or therapeutic purposes have occurred since that time. In fact, it is now becoming an established modality in the diagnosis and/or treatment of certain diseases, e.g., cancer, to introduce monoclonal antibodies or other tumor or lymph node localizing agents tagged with a radioactive isotope (e.g., Technetium 99 m, Indium 111, Iodine 123, and Iodine 125) into the body of the patient. Such radiopharmaceuticals tend to localize in particular tissue, such as the cancerous tissue, so that the gamma radiation emitted by the isotope agent can be detected by a radiation detector, e.g., a probe. In particular, the radiation detector or probe is disposed or positioned adjacent portion of the patient""s body where the cancerous tissue is suspected to be in order to detect if any radiation is emanating from that site. If it is this indicates that cancerous tissue is likely to be found at that site.
Prior art, hand-held, radiation detecting probes particularly suitable for such cancer-finding applications are commercially available from the assignee of this invention, Care Wise Medical Products, Inc., under the trademark C-TRAK. In U.S. Pat. Nos. 4,959,547 and 5,036,201 assigned to the same assignee as this invention there are disclosed hand-held radiation detecting probes having collimating means to establish the field of view or xe2x80x9csolid angle of acceptancexe2x80x9d of the probe. In U.S. Pat. Nos. 5,119,818 and 5,170,055, also assigned to the same assignee as this invention, there are disclosed hand-held radiation detecting probes and accessories optimized to biopsy radio-labeled tissues. In U.S. Pat. No. 4,801,803 (Donnan et al.) there is also disclosed a hand-held radiation detecting probe.
In the diagnosis and treatment of breast cancer and prostate cancer a radiopharmaceutical can be injected adjacent a detected tumor site, e.g., within the breast, to migrate to the closest draining lymph node (the xe2x80x9csentinelxe2x80x9d node) so that localization of that node and its examination can be readily effected in order to evaluate the extent, if any, of metastasis of the cancer. Heretofore, no minimally invasive instrument, e.g., radioactivity detection probe, has existed to not only detect or localize the radioactively tagged tissue, e.g., the sentinel node, but also to safely dislodge it from adjacent tissue and to ensnare or trap it so that it can be removed for analysis.
It is a general object of this invention to provide a minimally invasive surgical instrument and method of use which addresses that need and which overcomes the disadvantages of the prior art.
These and other objects of the subject invention are achieved by providing a probe for minimally invasive introduction within the body of a living being. The probe is arranged to detect radiation emanating from radioactively tagged tissue, e.g., a sentinel lymph node, within the being""s body to determine the location of that tissue. The probe is arranged to be readily manipulated and moved adjacent to the radioactively tagged tissue, and includes means (e.g., plural extendable members) for engaging (e.g., piercing or otherwise ensnaring) the radioactively tagged tissue to remove it from the being""s body.
In accordance with another aspect of this invention the probe also preferably comprises a blunt tissue dissector. The tissue dissector is arranged to bluntly separate the radioactively tagged tissue from adjacent tissue so that the radioactively tagged tissue may be readily removed from the being""s body.
In accordance with yet another aspect of the invention an attachment, e.g., a disposable sheath, for a radioactivity detecting probe is provided. The probe is a small device for minimally invasive introduction within the body of a living being to detect radiation emanating from radioactively tagged tissue, e.g., a sentinel lymph node, within the being""s body to thereby determine the location of that tissue. The probe is arranged to be readily manipulated and moved adjacent to the radioactively tagged tissue. The attachment is arranged to be initially mounted on the probe prior to use and basically comprises means (e.g., plural extendable members) for engaging (e.g., piercing or otherwise ensnaring) the radioactively tagged tissue to remove it from the being""s body.
In accordance with another aspect of this invention the attachment, e.g., sheath, also preferably comprises a blunt tissue dissecting device. The tissue dissecting device is arranged to bluntly separate the radioactively tagged tissue from adjacent tissue so that the radioactively tagged tissue may be readily removed from the being""s body.
In accordance with another preferred aspect of this invention, the instrument may be fully integrated and self-powered, or may be partially integrated and self-powered.
In any case the instrument, probe and/or attachment for a probe may include means for illuminating the situs of the radioactively tagged tissue and may also include means for visualizing that situs.